We currently do not have a blood irradiator in our Blood Bank but are working with our Radiation Oncology department to provide this service. I would like to know if any other facilities are irradiating products this way and what steps you took to validate the process. Also, we are currently not inspected by the FDA and were wondering if this would open us up to an inspection. Any information would be appreciated.

I think that you would need to register with the FDA and be subject to FDA inspections because that activity would be considered to be modifying a blood product. Comments from others who have more experience in this area?

FDA registration (and therefore inspections) is required as irradiation is considered "manufacturing", even if done under "contract" by the radiation department.

We have done it through our rad. oncology department for many years. Currently, we are serving only a few patients, and plan to have our blood center irradiate for us and drop the :bonk: FDA inspection. It is just not worth the grief they put you though for 3 VERY long days. They look at everything. Good luck.